Eligibility and Potential Benefit of Transcatheter Edge-to-Edge Repair in a Contemporary Cohort With Heart Failure: Evidence From a Large Integrated Health Care Delivery System

Andrew P Ambrosy; Jingrong Yang; Andrew S Tai; Sadia J Dimbil; Elisha A Garcia; Sue Hee Sung; Ankeet S Bhatt; Matthew D Solomon; Ivy A Ku; Jacob M Mishell; Edward J McNulty; Jonathan G Zaroff; Andrew N Rassi; Jeremy Kong; Alan S Go

doi:10.1016/j.shj.2023.100237

Eligibility and Potential Benefit of Transcatheter Edge-to-Edge Repair in a Contemporary Cohort With Heart Failure: Evidence From a Large Integrated Health Care Delivery System

Struct Heart. 2023 Dec 19;8(2):100237. doi: 10.1016/j.shj.2023.100237. eCollection 2024 Mar.

Authors

Andrew P Ambrosy^{1

2

3}, Jingrong Yang², Andrew S Tai⁴, Sadia J Dimbil⁴, Elisha A Garcia², Sue Hee Sung², Ankeet S Bhatt^{1

2

3}, Matthew D Solomon^{2

5}, Ivy A Ku¹, Jacob M Mishell¹, Edward J McNulty¹, Jonathan G Zaroff¹, Andrew N Rassi¹, Jeremy Kong¹, Alan S Go^{2

3

6

7}

Affiliations

¹ Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA.
² Division of Research, Kaiser Permanente Northern California, Oakland, California, USA.
³ Department of Health Systems Science, Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, California, USA.
⁴ Department of Medicine, Kaiser Permanente San Francisco Medical Center, San Francisco, California, USA.
⁵ Department of Cardiology, Kaiser Permanente Oakland Medical Center, Oakland, California, USA.
⁶ Departments of Epidemiology, Biostatistics and Medicine, University of California, San Francisco, San Francisco, California, USA.
⁷ Department of Medicine, Stanford University, Palo Alto, California, USA.

Abstract

Background: The eligibility and potential benefit of transcatheter edge-to-edge repair (TEER) in addition to guideline-directed medical therapy to treat moderate-severe or severe secondary mitral regurgitation (MR) has not been reported in a contemporary heart failure (HF) population.

Methods: Eligibility for TEER based on Food and Drug Administration (FDA) labeling: (1) HF symptoms, (2) moderate-severe or severe MR, (3) left ventricular ejection fraction (LVEF) 20% to 50%, (4) left ventricular end-systolic dimension 7.0 cm, and (5) receiving GDMT (blocker + angiotensin-converting enzyme inhibitor/angiotensin receptor blocker). The proportion (%) of patients eligible for TEER. The hypothetical number needed to treat to prevent or postpone adverse outcomes was estimated using relative risk reductions from published hazard ratios in the registration trial and the observed event rates.

Results: We identified 50,841 adults with HF and known LVEF. After applying FDA criteria, 2461 patients (4.8%) were considered eligible for transcatheter mitral valve replacement (FDA+), with the vast majority of patients excluded (FDA-) based on a lack of clinically significant MR (N = 47,279). FDA+ patients had higher natriuretic peptide levels and were more likely to have a prior HF hospitalization compared to FDA- patients. Although FDA+ patients had a more dilated left ventricle and lower LVEF, median (25th-75th) left ventricular end-systolic dimension (cm) was low at 4.4 (3.7-5.1) and only 30.8% had severely reduced LVEF. FDA+ patients were at higher risk of HF-related morbidity and mortality. The estimated number needed to treat to potentially prevent or postpone all-cause hospitalization was 4.4, 8.8 for HF hospitalization, and 5.3 for all-cause death at 24 months in FDA+ patients.

Conclusions: There is a low prevalence of TEER eligibility based on FDA criteria primarily due to absence of moderate-severe or severe MR. FDA+ patients are a high acuity population and may potentially derive a robust clinical benefit from TEER based on pivotal studies. Additional research is necessary to validate the scope of eligibility and comparative effectiveness of TEER in real-world populations.

Keywords: Functional; Heart failure; Mitral regurgitation; Transcatheter edge-to-edge repair.